U.S. patent application number 10/525728 was filed with the patent office on 2006-01-12 for multiway wave.
Invention is credited to Cesare Bulgarelli, Andrea Parrino.
Application Number | 20060005886 10/525728 |
Document ID | / |
Family ID | 31972204 |
Filed Date | 2006-01-12 |
United States Patent
Application |
20060005886 |
Kind Code |
A1 |
Parrino; Andrea ; et
al. |
January 12, 2006 |
Multiway wave
Abstract
What is provided is a flow shut-off element, particularly for
use in the medical field of peritoneal dialysis, consisting of a
valve body (2) having an inner cavity (3) and a plurality of
accesses (4, 5, 6); a selector having a projecting portion inserted
into the inner cavity of the valve body and movable relatively to
the latter into a predetermined number of operating positions to
create predetermined paths in which the fluid flow is permitted
and/or shut off between the said accesses. Also provided is an
auxiliary element interposed in a removable way between the valve
body and the selector, this element having positioning means to
enable an operator to determine when one of the said predetermined
operating positions of the selector has been reached.
Inventors: |
Parrino; Andrea; (Mirandola,
IT) ; Bulgarelli; Cesare; (San Possidonio,
IT) |
Correspondence
Address: |
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER;LLP
901 NEW YORK AVENUE, NW
WASHINGTON
DC
20001-4413
US
|
Family ID: |
31972204 |
Appl. No.: |
10/525728 |
Filed: |
August 5, 2003 |
PCT Filed: |
August 5, 2003 |
PCT NO: |
PCT/IB03/03166 |
371 Date: |
February 25, 2005 |
Current U.S.
Class: |
137/556 |
Current CPC
Class: |
Y10T 137/8359 20150401;
A61M 1/28 20130101; A61M 39/223 20130101; Y10T 137/86863 20150401;
Y10T 137/8275 20150401 |
Class at
Publication: |
137/556 |
International
Class: |
F16K 37/00 20060101
F16K037/00 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 6, 2002 |
IT |
MI2002A001895 |
Claims
1-30. (canceled)
31. Flow shut-off element comprising: a valve body having an inner
cavity and a plurality of accesses communicating with said inner
cavity to allow a flow of fluid; a selector associated with said
valve body and movable relatively to the latter into a
predetermined number of operating positions, said selector being
active in said inner cavity to form, as a result of movements into
said operating positions, predetermined paths in which the fluid
flow is permitted and/or shut off between said accesses; and an
auxiliary element associated with said valve body and made in the
form of an independent body, said auxiliary element being provided
with positioning means to enable an operator to determine when one
of said predetermined operating positions of said selector has been
reached.
32. Element according to claim 31, wherein said selector comprises
a predetermined number of catches and/or notches designed to
interact with said positioning means to make it possible to
perceive when said predetermined operating positions of said
selector have been reached.
33. Element according to claim 32, wherein said positioning means
have at least one corresponding catch and/or notch designed to be
engaged in at least one of said notches and/or catches.
34. Element according to claim 31, wherein said positioning means
comprise an elastic element having a locking catch designed to
interact with corresponding notches present in said selector.
35. Element according to claim 32, wherein the notches of said
selector are formed in an essentially circular ring of the
selector.
36. Element according to claim 31, wherein said selector comprises
a projecting portion designed to be inserted, in operating
conditions, into the inner cavity of said valve body, relative
movements of said selector with respect to the valve body and to
the auxiliary element causing different operating positions to be
reached.
37. Element according to claim 36, wherein a circular ring of
notches of said selector is essentially coaxial with said
projecting portion, interacting with the latter to delimit a cavity
for engagement with said valve body.
38. Element according to claim 34, wherein said locking catch is
positioned at a free end of said elastic element.
39. Element according to claim 34, wherein said elastic element has
an essentially curved axis of extension.
40. Element according to claim 31, wherein said positioning means
comprise a stop projection to form a mechanical stop to the
movement of said selector.
41. Element according to claim 31, wherein said positioning means
are shaped in such a way as to permit a relative rotation of said
selector with respect to said valve body in only one direction.
42. Element according to claim 31, wherein said auxiliary element
has a central through cavity.
43. Element according to claim 42, wherein said positioning means
comprise a locking catch designed to interact with corresponding
notches present in said selector, and a stop projection to form a
mechanical stop to the movement of said selector, said locking
catch and stop projection face towards said central through cavity
of said auxiliary element.
44. Element according to claim 36, wherein said projecting portion
of said selector is of essentially cylindrical shape and is at
least partially shaped to be complementary to said inner cavity of
said valve body.
45. Element according to claim 36, wherein said selector is movable
with respect to said valve body and about an axis of rotation, said
projecting portion being preferably cylindrical and having its axis
of extension coinciding with the axis of rotation.
46. Element according to claim 36, wherein said projecting portion
comprises predetermined channels designed to interact with said
accesses formed in said valve body to create different fluid paths
within said shut-off element according to the relative positions of
said selector with respect to said valve body.
47. Element according to claim 31, wherein said valve body
comprises at least a first, a second and a third access for the
fluid, said selector being capable at least of switching said
shut-off element between a condition in which the flow of fluid is
prevented, a condition in which fluid flows from the third to the
second access, a condition in which fluid flows from the first to
the second access, and a condition in which fluid flows from the
first to the third access.
48. Element according to claim 31, wherein said selector has at
least one aperture, different relative positions of said selector
with respect to said valve body providing visual access through
said aperture to corresponding different areas of said auxiliary
element.
49. Element according to claim 31, wherein said body has on one of
its surfaces facing said selector predetermined visual
representations, said representations being graphic symbols and/or
alphanumeric indications and/or colours relating to the paths in
which the fluid flow is shut off and/or permitted between said
accesses.
50. Element according to claim 31, wherein said selector has a grip
portion to enable a user to rotate it with respect to said valve
body.
51. Element according to claim 50, wherein said grip portion is
delimited by stiffening ribs extending transversely with respect to
an axis of rotation.
52. Element according to claim 37, wherein said valve body has an
inner perimetric wall forming said inner cavity, an upper portion
of said perimetric wall being designed to be inserted and guided in
its movement by the engagement cavity of the selector.
53. Element according to claim 31, wherein, in conditions of
engagement of said valve body with said auxiliary element, the
inner perimetric wall passes through the central through
cavity.
54. Element according to claim 31, wherein the selector and/or the
valve body and/or the auxiliary element are essentially discoid in
shape.
55. Element according to claim 36, wherein said projecting portion,
in operating conditions, is inserted in a fluid-tight way into the
inner cavity of the valve body.
56. Element according to claim 31, wherein said valve body has at
least one or several locating blocks to enable the auxiliary
element to be positioned correctly on said valve body.
57. Element according to claim 56, wherein said auxiliary element
has corresponding notches designed to receive said locating blocks
of the valve body.
58. Element according to claim 31, wherein said auxiliary element
is removably associated with said valve body.
59. Flow shut-off element comprising: a valve body having an inner
cavity and a plurality of accesses communicating with said inner
cavity to permit a flow of fluid; a selector associated with said
valve body and movable relatively to the latter into a
predetermined number of operating positions, said selector being
active in said inner cavity to form, as a result of movements into
said operating positions, predetermined paths in which the fluid
flow is permitted and/or shut off between said accesses; and an
auxiliary element associated with said valve body, said auxiliary
element having on one of its surfaces facing the selector
predetermined visual representations, said representations being
graphic symbols and/or alphanumeric indications and/or colours
relating to the paths in which the fluid is shut off and/or flows
within the shut-off element.
60. Flow shut-off element comprising: a valve body having an inner
cavity and a plurality of accesses communicating with said inner
cavity to permit a flow of fluid; a selector associated with said
valve body and movable relatively to the latter into a
predetermined number of operating positions, said selector being
active in said inner cavity to form, as a result of movements into
said operating positions, predetermined paths in which the fluid
flow is permitted and/or shut off between said accesses; and an
auxiliary element removably associated with said valve body and
made in the form of an independent body, said auxiliary element
being provided with positioning means to enable an operator to
determine when one of said predetermined operating positions of the
selector has been reached, said selector comprising an essentially
circular ring in which is formed a predetermined number of notches
designed to interact with at least one corresponding catch of said
positioning means, said catch being designed to be engaged in said
notches.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention relates to a flow shut-off
element.
[0002] In particular, the flow shut-off element according to the
present invention is intended for applications in the medical field
and, in greater detail, this device can be used in circuits for
peritoneal dialysis.
[0003] As is known, a circuit for peritoneal dialysis consists of
at least one tube connected to the patient's peritoneal cavity; in
practice, the tube consists of a surgically implanted fixed
catheter having an outlet inside the peritoneal cavity, and a
portion outside the body to which is connected a further length of
tubing designed to be replaced periodically.
[0004] The circuit thus has a first infusion line connected to one
or more bags containing fresh fluid for introduction into the
patient's peritoneal cavity and a second drainage line for the
waste fluid, designed to carry the fluid located in the patient's
peritoneal cavity to one or more bags for subsequent disposal.
[0005] In particular, the infusion and drain lines are joined by a
Y-connector to a third line in communication with the fixed
catheter and consequently with the peritoneal cavity.
[0006] Briefly, in a peritoneal dialysis operation the dialysis
fluid which has remained for the necessary time in the patient's
peritoneal cavity has to be drained off and sent to the collection
bags for disposal, and the Y-connector then has to be flushed
through by passing fresh fluid from the infusion line to the drain
line, after which, in a final stage of infusion, a fresh fluid has
to be introduced into the patient's peritoneal cavity.
[0007] Consequently, in order to carry out the aforesaid
operations, it is necessary to use shut-off elements capable of
operating in the area of the junction between the various tubes to
ensure the correct flow of the fluids.
[0008] A first known technique requires the use of clamps (at least
one for each tube), which are operated manually, thus mechanically
deforming the tubing to the point at which its cross section is
completely closed.
[0009] In particular, for carrying out the aforesaid operations,
the infusion line is first closed to allow the fluid to pass from
the patient towards the disposable bags; secondly the tubing
leading towards the peritoneal cavity is closed, enabling the
connection area to be washed by passing fresh fluid towards the
disposable fluid bag, after which the drain line is closed, thus
allowing fresh fluid to be introduced into the peritoneal
cavity.
[0010] Clearly, since manual opening and closing operations have to
be performed on the tubing, a degree of experience and attention is
required from the user who might otherwise make mistakes in the
sequence of stages, or even carry out incorrect operations which
could result in serious harm to the patient's health.
[0011] A further known technique according to Patent no. EP 768099
requires the use of a stopcock consisting of a valve body on which
three channels for the passage of fluids converge.
[0012] The valve body has a central cavity which communicates with
the aforesaid channels, and which is designed to receive a
projecting portion of a movable selector.
[0013] The rotation of the selector creates different paths for the
fluid within the stopcock, these paths being created simply by the
angular position of the said selector.
[0014] This stopcock is also provided with suitable projections
located within the cavity formed by the valve body, and with
corresponding notches formed on a cylindrical portion of the said
selector.
[0015] In practice, the function of these elements is to signal to
the user that the correct angular positions of the selector have
been reached, these positions providing an optimal predetermined
passage of fluid within the stopcock.
[0016] However, the known technique summarized above has certain
drawbacks and/or operational limitations.
[0017] In the first place, the valves of the known type described
above have no versatility at all, and are difficult to adapt.
[0018] If these devices were to be modified and/or adapted in any
way, it would be necessary to replace most parts, if not all, of
the stopcock.
[0019] Furthermore, with the aforementioned shut-off element it is
not possible to specify the sequence of successive operations which
the valve is to perform; in particular, the operator only has the
sensation of correct positioning in the various operating
conditions, but there is no indication as to the correctness of the
valve opening/closing sequence being executed by the device.
SUMMARY OF THE INVENTION
[0020] The object of the present invention is therefore essentially
to overcome the aforesaid drawbacks.
[0021] A first object of the invention is to provide a flow
shut-off element which is as versatile and adaptable as
possible.
[0022] A further object of the invention is to maintain maximum
reliability of the device without essentially detracting from the
intrinsic simplicity of construction of the known devices, and
while also keeping the costs low, in view of the fact that the
valves to which the invention relates are generally of the
disposable type.
[0023] A subsidiary object of the invention is to provide a
shut-off element in which the correct sequence of operations is
made compulsory, in such a way that a user cannot inadvertently
carry out these operations in an incorrect temporal sequence.
[0024] Finally, a further object is to prevent the re-use of these
valves when they have already been used.
[0025] These and other objects which will be made clear in the
course of the description are essentially achieved by a flow
shut-off element according to the present claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] Further characteristics and advantages will be made clear by
the following detailed description of a preferred, but not
exclusive, embodiment of a flow shut-off element according to the
illustrations in the attached drawings, in which:
[0027] FIG. 1 shows a perspective view of a valve body according to
the present invention;
[0028] FIG. 2 shows a view from above of the body of FIG. 1;
[0029] FIG. 3 shows a transverse section through the valve body
shown in FIG. 1;
[0030] FIG. 4 shows a longitudinal section through the valve body
shown in FIG. 1;
[0031] FIG. 5 shows an auxiliary element which can be associated
with the valve body shown in FIG. 1;
[0032] FIG. 6 shows a detail of the positioning means of the
auxiliary element of FIG. 5;
[0033] FIG. 7 shows a lateral view in partial section of the
auxiliary element of FIG. 5;
[0034] FIG. 8 shows in a perspective view from above a selector
which can be associated with the valve body shown in FIG. 1;
[0035] FIG. 9 shows in a perspective view from below the selector
shown in FIG. 8;
[0036] FIG. 10 shows in a lateral view the selector shown in FIG.
8;
[0037] FIG. 11 shows a section taken through the line A-A of the
selector of FIG. 10;
[0038] FIG. 12 shows a transverse section taken through the line
B-B of the selector of FIG. 10;
[0039] FIG. 13 shows in a schematic way a variant of the auxiliary
element of FIG. 5; and
[0040] FIG. 14 shows in a schematic way a circuit for peritoneal
dialysis.
DETAILED DESCRIPTION
[0041] With reference to the aforesaid figures, the number 1
indicates the whole of a flow shut-off element for use, in
particular, in medical applications, and more particularly in
circuits for peritoneal dialysis.
[0042] As shown in FIG. 14, the shut-off element 1 is designed to
operate (as explained more fully below) in the area of the junction
of the infusion line 100 and the drain line 200 with the inlet line
300 leading to the patient's peritoneal cavity.
[0043] To provide greater structural detail, it can be seen that
the shut-off element consists of a valve body 2 (see FIGS. 1 to 4)
which has an essentially discoid profile and has a plurality of
accesses 4, 5 and 6, of which there are three in this particular
case, designed to be connected, respectively, to the infusion line
100, to the drain line 200, and to the patient line 300.
[0044] In particular, the terminal portions of the tubes forming
the aforementioned lines are engaged with the projecting portions
of these accesses and the connection is secured by the friction
generated between the material forming the tubes and the material,
for example polycarbonate, from which the valve body is made.
[0045] The accesses 4, 5 and 6 thus form three channels which can
put the infusion line 100, drain line 200 and patient line 300
directly into fluid communication with an inner cavity 3 of the
valve body 2.
[0046] The flow shut-off element 1 also comprises a selector 7 (see
FIGS. 8 to 12) also of essentially discoid shape, which can be
associated with the valve body 2 and is movable relatively to the
latter into a predetermined number of operating positions in which
it forms, by interacting with the said valve body, predetermined
paths in which the flow of the fluid is permitted and/or shut off
between the said accesses 4, 5 and 6.
[0047] In particular, the selector, made for example from
polyethylene by injection moulding, is provided with a projecting
portion 13 which has an essentially cylindrical profile and is at
least partially shaped in a complementary way to the inner cavity 3
of the valve body 2.
[0048] It should be noted that the portion 13 can alternatively
have a conical shape (obviously with a small degree of taper), in
order to improve the fluidtightness between the said portion 13 and
the cavity 3.
[0049] In particular, in operating conditions, the selector 7 is
mounted on the valve body 2 in such a way that the projecting
portion 13 is inserted into the cavity 3 in a fluidtight way.
[0050] The projecting portion 13 has a cross section (shown in FIG.
11) in which can be seen channels 16 designed to interact with the
accesses 4, 5 and 6 formed in the valve body 2 in order to create
various paths for the fluid within the shut-off element, according
to the relative angular positions of the selector 7 and the valve
body 2.
[0051] In detail, the first, second and third accesses 3, 4 and 5
are brought into fluid communication in a predetermined sequence by
relative rotations of the selector about the axis of rotation
15.
[0052] According to the peritoneal dialysis procedure, the selector
7 must be capable of switching the shut-off element at least
between a condition in which the flow of fluid is prevented; a
condition in which fluid passes from the third to the second access
6, 5, in which the fluid is allowed to drain from the patient's
peritoneal cavity 301 to the waste bags 201; a condition in which
fluid passes from the first to the second access 4, 5, in which the
connector is washed by making fresh fluid pass towards the waste
bag 201; and a condition in which fluid passes from the first to
the third access 4, 6, in which fresh fluid can be infused from the
bags 101 into the patient's peritoneal cavity 301. The
configuration of the channels 16 and the arrangement of the
accesses 4, 5 and 6 is such that a rotation of the selector from an
initial position in the direction of the arrow 23 shown in FIG. 8
makes it possible to pass in succession from the fluid flow
shut-off condition to the drain condition, to the washing condition
and then to the infusion condition, finally reaching a condition in
which the passage of fluid is stopped within the shut-off
element.
[0053] Advantageously, the shut-off element according to the
present invention also comprises an auxiliary element 8 shown in
FIGS. 5, 6, 7 and 13, which also has an essentially discoid shape
and is designed to be removably associated with the valve body
2.
[0054] In this context it should be noted that the valve body 2 is
provided with one or preferably numerous locating blocks 25, which,
more precisely, consist of small catches projecting from the
channels 4, 5 and 6 (see FIG. 1); these locating blocks enable the
auxiliary element 8 to be positioned correctly on the said valve
body.
[0055] As can be seen in FIG. 7, the auxiliary element 8 has
corresponding notchs 26 designed to receive the said locating
blocks 25 of the valve body 2.
[0056] During assembly, the auxiliary element 8 is positioned to
bear on the valve body 2 and then the projecting portion 13 of the
selector is inserted into the cavity 3 of the valve body where it
is engaged by a snap fit.
[0057] It should also be noted that the valve body has an inner
perimetric wall 21 delimiting the inner cavity 3.
[0058] In a corresponding way, the auxiliary element 8 has a
central through cavity 24, through which an upper portion 21a of
the perimetric wall 21 passes during assembly.
[0059] The selector 7 is also provided with a circular ring 7a
which is coaxial with the projecting portion 13 and interacts with
this portion to delimit a cavity 14 for engagement with the valve
body 2.
[0060] In other words, the upper portion 21a of the perimetric wall
21 is designed to be inserted and guided in its movement by the
engagement cavity 14 of the said selector into a condition in which
the various components are engaged.
[0061] Turning now to the illustration in FIG. 5, it can be seen
that the auxiliary element 8 is provided with positioning means 9
for determining when one of the predetermined operating positions
of the selector is reached.
[0062] In particular, the selector 7 can comprise a predetermined
number of catches and/or notches 10 (a plurality of notches being
provided in the illustrated embodiment), while the positioning
means 9 can have at least one corresponding catch or notch 11 (in
the present case, a single locking catch is provided) designed to
engage in at least one of the said catches and/or notches 10.
[0063] The positioning means 9 consist, in particular, of an
elastic element 12 which extends along a curved axis from the main
body of the auxiliary element 8 and has the locking catch 11 at its
free end. This catch 11 interacts, in particular, with the notches
10 of the selector 7, which are formed on the aforesaid circular
ring 7a. In particular, following a rotation of the selector 7, the
configuration of the notches 10 and the catch 11 is such that the
elastic element 12 is deformed in a radial direction until the
catch 11 snaps into an angularly successive notch 10.
[0064] The particular configuration of the catch 11 and the notches
10 is such that the selector 7 can rotate with respect to the valve
body 2 only in the direction indicated by the number 23 in FIG.
8.
[0065] Rotation in the opposite direction is prevented by the
undercut of the catch 11 which bears on the corresponding undercuts
formed in the circular ring of the selector (see, in particular,
FIG. 9).
[0066] It can be seen in FIG. 6 that the positioning means 9 also
comprise a stop projection 22 which can form a mechanical stop to
the rotary movement of the selector 7.
[0067] In particular, the function of the stop projection 22 is to
delimit the end of travel of the selector 7.
[0068] In other words, when the valve body 2, the auxiliary element
8 and the selector 7 have been assembled together in the correct
initial position, it is possible to make successive rotations of
the selector in the direction indicated by the arrow 23 of FIG. 8
into the various operating conditions of the shut-off element.
[0069] The reaching of the various stages of operation is indicated
by the snap-fitting of the catch 11 into the corresponding notches
10, and, when all the operating positions have been passed through
in sequence, the stop projection 22 interacts with the said notches
10 and thus prevents further rotation in the direction of the arrow
indicated by the reference 23.
[0070] At the same time, the catch 11 inserted into another
corresponding notch 10 prevents movement in the reverse direction,
thus effectively preventing the re-use of the shut-off element.
[0071] Finally, it should be noted that the selector 7 has at least
one aperture 17 for permitting views of corresponding areas of the
underlying auxiliary element.
[0072] Thus different positions of the selector 7 relative to the
valve body 2 enable different portions of the upper surface 8a of
the auxiliary element 8 to be viewed.
[0073] This upper surface 8a has, in particular, predetermined
visual representations 18 illustrated by way of example in FIGS. 5
and 13.
[0074] The representations 18 can be, in particular, graphic
symbols and/or alphanumeric indications and/or colours relating to
the paths in which the fluid flow is permitted and/or shut off
between the said accesses.
[0075] With reference to the screen-printed auxiliary element shown
in FIG. 5, it can be seen that, in the initial assembly position,
the aperture 17 is located over the wording "START"; a first
rotation in the direction of the arrow 23 places the aperture over
the wording "DRAIN" and at the same time the shut-off element moves
from a condition in which no flow of fluid is permitted within the
cavity 3 to a condition in which the fluid is allowed to drain from
the patient's peritoneal cavity 310 to the waste bags 201.
[0076] A further rotation of the selector 7 places the aperture 17
over the wording "FLUSH", where the shut-off element is in the
flushing condition, allowing fresh fluid to flow towards the waste
bags 201.
[0077] A further rotation places the aperture 17 over the wording
"FILL" and the configuration of the shut-off element is such that
fresh fluid is allowed to flow towards the patient's peritoneal
cavity 301.
[0078] A further rotation in the clockwise direction then places
the aperture over the wording "END" in which no flow of fluid is
permitted within the shut-off element.
[0079] In this final condition, it is no longer possible to carry
out any rotation in either the clockwise or the anti-clockwise
direction, and the said shut-off element therefore has to be
removed.
[0080] Finally, as shown in FIG. 8, the selector 7 has a grip
portion 19 to enable the operator to rotate it with respect to the
valve body 2; the grip portion 19 is, in particular, formed by
suitable stiffening ribs 20 which extend transversely with respect
to the axis of rotation 15.
[0081] The invention yields considerable advantages.
[0082] In the first place, the presence of an auxiliary body, which
carries the screen-printed wording relating to the operations which
the shut-off element is executing and also carries the positioning
means which provide an active indication of the reaching of the
correct position, imparts a greater versatility to the device.
[0083] This is because the shut-off element can be adapted simply
by replacing the auxiliary disc in such a way that the wording
and/or graphic representations appearing on it can be modified.
[0084] Additionally, a modification of the positioning means of
this auxiliary element makes it possible to carry out larger or
smaller relative rotations and to stop the shut-off element in
different angular positions.
[0085] These advantages are achieved without essentially affecting
the simplicity of construction and the production costs of the
shut-off element, which has to be replaced after every use.
[0086] Furthermore, the particular configuration of the positioning
means and of the corresponding notches present on the selector make
it possible to specify a single direction of rotation and therefore
a sequence of the possible operations to be executed, with no
possibility of any error by the operator.
* * * * *